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NDC 50458-0253-03 Haldol Decanoate 50 mg/mL Details
Haldol Decanoate 50 mg/mL
Haldol Decanoate is a INTRAMUSCULAR INJECTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Janssen Pharmaceuticals, Inc.. The primary component is HALOPERIDOL DECANOATE.
MedlinePlus Drug Summary
Haloperidol injection and haloperidol extended-release injection are used to treat schizophrenia (a mental illness that causes disturbed or unusual thinking, loss of interest in life, and strong or inappropriate emotions). Haloperidol injection is also used to control motor tics (uncontrollable need to repeat certain body movements) and verbal tics (uncontrollable need to repeat sounds or words) in people who have Tourette's disorder (condition characterized by motor or verbal tics). Haloperidol is in a class of medications called conventional antipsychotics. It works by decreasing abnormal excitement in the brain.
Related Packages: 50458-0253-03Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Haloperidol Injection
Product Information
| NDC | 50458-0253 |
|---|---|
| Product ID | 50458-253_f911a4fb-4b5c-ba34-e053-6394a90a202a |
| Associated GPIs | 59100010302010 |
| GCN Sequence Number | 003966 |
| GCN Sequence Number Description | haloperidol decanoate AMPUL 50 MG/ML INTRAMUSC |
| HIC3 | H7O |
| HIC3 Description | ANTIPSYCHOTICS,DOPAMINE ANTAGONISTS,BUTYROPHENONES |
| GCN | 14800 |
| HICL Sequence Number | 001660 |
| HICL Sequence Number Description | HALOPERIDOL DECANOATE |
| Brand/Generic | Brand |
| Proprietary Name | Haldol Decanoate |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Haloperidol Decanoate |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | INJECTION |
| Route | INTRAMUSCULAR |
| Active Ingredient Strength | 50 |
| Active Ingredient Units | mg/mL |
| Substance Name | HALOPERIDOL DECANOATE |
| Labeler Name | Janssen Pharmaceuticals, Inc. |
| Pharmaceutical Class | Typical Antipsychotic [EPC] |
| DEA Schedule | n/a |
| Marketing Category | NDA |
| Application Number | NDA018701 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 50458-0253-03 (50458025303)
| NDC Package Code | 50458-253-03 |
|---|---|
| Billing NDC | 50458025303 |
| Package | 3 AMPULE in 1 BOX (50458-253-03) / 1 mL in 1 AMPULE |
| Marketing Start Date | 1986-01-14 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |